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Progestin Treatment for Endometrial Stromal Cells in Adenomyosis

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ClinicalTrials.gov Identifier: NCT00155051
Recruitment Status : Unknown
Verified June 2004 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : September 12, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Study Description
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Brief Summary:

Long term treatment of progestin has been demonstrated to have an inhibitory effect on endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result, progestin is now widely employed in the treatment of endometrial cancer, endometrial hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the beneficial effect of progestin was limited. It might imply that the behavior of endometrial cells in women with adenomyosis is different from that in women without adenomyosis.

Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK cells was decreased in eutopic endometrium in women with adenomyosis. It may be a compensatory effect in which the NK cytotoxicity is activated in order to wipe out the abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies that the formation of adenomyosis might be due to “abnormal” endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. This finding is compatible with previous reports in which eutopic endometrium obtained from women with endometriosis or adenomyosis was found to behave differently from endometrium in unaffected women.

In this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify the endometrial stromal cells from endometrium. The endometrial stromal cells are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or danazol. Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations of IL-6 and IL-8 in cultured media will be done with real time RT-PCR and ELISA respectively. The expression of different cytokines of endometrial cells in response to progestin might be further elucidated after our experiment.


Condition or disease
Endometriosis

Detailed Description:

Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group).

After becoming pre-confluent (covering 80% of the culture well), ESC was cultured for 8 days solely or with the addition of medroxyprogesterone (MPA) or danazol.

ELISA was done to measure IL-6, IL-8, and TNF-alpha concentrations of the culture media.

Real-time quantitative RT-PCR was done to measure IL-6, IL-8, and TNF-alpha RNA levels in ESC.


Study Design
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Study Type : Observational
Enrollment : 45 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Study Start Date : July 2004
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women with adenomyosis
  • at early- to mid-secretory phases

Exclusion Criteria:

  • postmenopausal
  • malignancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155051


Contacts
Contact: Jehn-Hsiahn Yang, M.D. 886-2-2312-3456 ext 3210 jhyang@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jehn-Hsiahn Yang, M.D.    886-2-2312-3456 ext 3210    jhyang@ha.mc.ntu.edu.tw   
Principal Investigator: Jehn-Hsiahn Yang, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jehn-Hsiahn Yang, M.D. Department of Obstetrics and Gynecology, National Taiwan University Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00155051     History of Changes
Other Study ID Numbers: 9361700762
NTUH.94S72
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: September 12, 2005
Last Verified: June 2004

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female